Federal Register / Vol. 71, No. 185 / Monday, September 25, 2006 / Notices 55799 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Dated: September 19, 2006. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 06–8110 Filed 9–22–06; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006E–0031] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; CLOLAR 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

CLOLAR and is publishing this notice of 

that determination as required by law. 

FDA has made the determination 

because of the submission of an 

application to the Director of Patents 

and Trademarks, Department of 

Commerce, for the extension of a patent 

which claims that human drug product. 

ADDRESSES: Submit written comments 

and petitions to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy (HFD–007), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–594–2041. 

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Public Law 98–

417) and the Generic Animal Drug and 

Patent Term Restoration Act (Public 

Law 100–670) generally provide that a 

patent may be extended for a period of 

up to 5 years so long as the patented 

item (human drug product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the human drug 

product becomes effective and runs 

until the approval phase begins. The 

approval phase starts with the initial 

submission of an application to market 

the human drug product and continues 

until FDA grants permission to market 

the drug product. Although only a 

portion of a regulatory review period 

may count toward the actual amount of 

extension that the Director of Patents 

and Trademarks may award (for 

example, half the testing phase must be 

subtracted as well as any time that may 

have occurred before the patent was 

issued), FDA’s determination of the 

length of a regulatory review period for 

a human drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(1)(B). 

FDA recently approved for marketing 

the human drug product CLOLAR 

(clofarabine). CLOLAR is indicated for 

the treatment of pediatric patients 1 to 

21 years old with relapsed or refractory 

acute lymphoblastic leukemia after at 

least two prior regimens. Subsequent to 

this approval, the Patent and Trademark 

Office received a patent term restoration 

application for CLOLAR (U.S. Patent 

No. 5,661,136) from Southern Research 

Institute, and the Patent and Trademark 

Office requested FDA’s assistance in 

determining this patent’s eligibility for 

patent term restoration. In a letter dated 

February 24, 2006, FDA advised the 

Patent and Trademark Office that this 

human drug product had undergone a 

regulatory review period and that the 

approval of CLOLAR represented the 

first permitted commercial marketing or 

use of the product. Shortly thereafter, 

the Patent and Trademark Office 

requested that FDA determine the 

product’s regulatory review period. 

FDA has determined that the 

applicable regulatory review period for 

CLOLAR is 2,200 days. Of this time, 

1,926 days occurred during the testing 

phase of the regulatory review period, 

while 274 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

355(i)) became effective: December 22, 

1998. The applicant claims February 10, 

1999, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was December 22, 

1998, the date FDA removed the clinical 

hold on the application. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: March 30, 2004. The 

applicant claims September 26, 2003, as 

the date the new drug application 

(NDA) for CLOLAR (NDA 21–673) was 

initially submitted. However, FDA 

records indicate that NDA 21–673 was 

submitted in its entirety on March 30, 

2004. 

3. The date the application was 

approved: December 28, 2004. FDA has 

verified the applicant’s claim that NDA 

21–673 was approved on December 28, 

2004. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the U.S. Patent and 

Trademark Office applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 1,303 days of patent 

term extension. 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments and ask for a 

redetermination by November 24, 2006. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

March 26, 2007. To meet its burden, the 

petition must contain sufficient facts to 

merit an FDA investigation. (See H. 

Rept. 857, part 1, 98th Cong., 2d sess., 

pp. 41–42, 1984.) Petitions should be in 

the format specified in 21 CFR 10.30. 

Comments and petitions should be 

submitted to the Division of Dockets 

Management. Three copies of any 

mailed information are to be submitted, 

except that individuals may submit one 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. Comments and petitions may 

be seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: September 1, 2006. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 06–8115 Filed 9–22–06; 8:45 am] 

BILLING CODE 4160–01–S 


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